s are allowed for other uses than preservation., BASIC BROWN 17

SOURCE_SUBDIR=sccs_o_091; REPORT_TITLE=OPINION ON Soytrimonium chloride COLIPA n° P72; OPINION_NUMBER=SCCS/1464/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 April 2006; VALUE_TEXT=63; DOSE=The authors conclude that cetrimonium bromide, when continuously administered in large doses, may potentially prevent proper nutrition by increasing the rate of gastric emptying and intestinal transit and/or by interfering with the absorption of nutritional substances.; LOAEL_VALUE=10 mg/kg bw/day; EFFECT=tion. The authors conclude that cetrimonium bromide, when continuously administered in large doses, may potentially prevent proper nutrition by increasing the rate of gastric emptying and intestinal transit and/or by interfering with the absorption of nutritional substances. Ref.: 35 (subm 2004) Comment Slight systemic effects were observed. Suppression of growth was also observed with another quaternary ammonium compound, alkyl dimethyl benzyl ammonium chloride, at a dosage of about 63 mg/kg b.w./day (LOAEL, no NOAEL derived; study cited in Ref. 31) For the calculation of the MoS, the NOAEL of 10 mg/kg bw/day for the analogous substance Cetrimonium bromide appears appropriate. Although this NOAEL may be the consequence of a local effect in the gastrointestinal tract, this NOAEL could be used as a conservative approach in the MoS calculation. B. Steartrimonium chloride - chronic toxicity No data submitted C. Behentrimonium chloride - chronic toxicity No data submitted D. Soytrimonium chloride - chronic toxicity No data s; CITATION=Ref.: 35 (subm 2004) Comment Slight systemic effects were observed; CITATION_NUMBERS=[35,2004]; REFERENCE=Ref.: 35 (subm 2004) Comment Slight systemic effects were observed; DETAILS_JSON={"cas_number":"61790-41-8","citation":"Ref.: 35 (subm 2004) Comment Slight systemic effects were observed","dose":"The authors conclude that cetrimonium bromide, when continuously administered in large doses, may potentially prevent proper nutrition by increasing the rate of gastric emptying and intestinal transit and/or by interfering with the absorption of nutritional substances.","duration":"chronic","effect":"tion. The authors conclude that cetrimonium bromide, when continuously administered in large doses, may potentially prevent proper nutrition by increasing the rate of gastric emptying and intestinal transit and/or by interfering with the absorption of nutritional substances. Ref.: 35 (subm 2004) Comment Slight systemic effects were observed. Suppression of growth was also observed with another quaternary ammonium compound, alkyl dimethyl benzyl ammonium chloride, at a dosage of about 63 mg/kg b.w./day (LOAEL, no NOAEL derived; study cited in Ref. 31) For the calculation of the MoS, the NOAEL of 10 mg/kg bw/day for the analogous substance Cetrimonium bromide appears appropriate. Although this NOAEL may be the consequence of a local effect in the gastrointestinal tract, this NOAEL could be used as a conservative approach in the MoS calculation. B. Steartrimonium chloride - chronic toxicity No data submitted C. Behentrimonium chloride - chronic toxicity No data submitted D. Soytrimonium chloride - chronic toxicity No data s","endpoint":"","ingredient":"s are allowed for other uses than preservation.","loael_value":"10 mg/kg bw/day","noael_unit":"mg/kg","noael_value":"63","page":31,"route":"","species":"","study_id":"sccs_o_091_noael_004"}

sccs_o_091.pdf

{"citation":"Ref.: 1 (subm 2004) Taken from SCCS/1246/09 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstear","effect":"SCCS/1464/12 Opinion on soytrimonium chloride (P72) ___________________________________________________________________________________________ 33 B. Steartrimonium chloride - dermal administration, rat Under the test conditions used, steartrimonium chloride was not found to be foetotoxic and teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was about 12.5 mg steartrimonium chloride/kg bw/day (highest concentration tested). Ref.: 1 (subm 2004) Taken from SCCS/1246/09 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstearylammonium chloride and trimethylstearylammonium chloride were investigated upon topical application of concentrations up to 9.9%, 6.6% and 2.5%, respectively. The authors conclude that, wi","page":33,"pdf":"sccs_o_091.pdf","row_type":"noael_study","study_id":"sccs_o_091_noael_009"}

sccs_o_091.pdf

{"citation":"Ref.: 1 (subm 2004) Taken from SCCS/1246/09 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstear","effect":"SCCS/1464/12 Opinion on soytrimonium chloride (P72) ___________________________________________________________________________________________ 33 B. Steartrimonium chloride - dermal administration, rat Under the test conditions used, steartrimonium chloride was not found to be foetotoxic and teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was about 12.5 mg steartrimonium chloride/kg bw/day (highest concentration tested). Ref.: 1 (subm 2004) Taken from SCCS/1246/09 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstearylammonium chloride and trimethylstearylammonium chloride were investigated upon topical application of concentrations up to 9.9%, 6.6% and 2.5%, respectively. The authors conclude that, wi","page":33,"pdf":"sccs_o_091.pdf","row_type":"noael_study","study_id":"sccs_o_091_noael_009"}

sccs_o_091.pdf

{"citation":"Ref.: 1 (subm 2004) Taken from SCCS/1246/09 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstear","effect":"SCCS/1464/12 Opinion on soytrimonium chloride (P72) ___________________________________________________________________________________________ 33 B. Steartrimonium chloride - dermal administration, rat Under the test conditions used, steartrimonium chloride was not found to be foetotoxic and teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was about 12.5 mg steartrimonium chloride/kg bw/day (highest concentration tested). Ref.: 1 (subm 2004) Taken from SCCS/1246/09 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstearylammonium chloride and trimethylstearylammonium chloride were investigated upon topical application of concentrations up to 9.9%, 6.6% and 2.5%, respectively. The authors conclude that, wi","page":33,"pdf":"sccs_o_091.pdf","row_type":"noael_study","study_id":"sccs_o_091_noael_009"}

sccs_o_091.pdf

{"citation":"Ref.: 1 (subm 2004) Taken from SCCS/1246/09 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstear","effect":"SCCS/1464/12 Opinion on soytrimonium chloride (P72) ___________________________________________________________________________________________ 33 B. Steartrimonium chloride - dermal administration, rat Under the test conditions used, steartrimonium chloride was not found to be foetotoxic and teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was about 12.5 mg steartrimonium chloride/kg bw/day (highest concentration tested). Ref.: 1 (subm 2004) Taken from SCCS/1246/09 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstearylammonium chloride and trimethylstearylammonium chloride were investigated upon topical application of concentrations up to 9.9%, 6.6% and 2.5%, respectively. The authors conclude that, wi","page":33,"pdf":"sccs_o_091.pdf","row_type":"noael_study","study_id":"sccs_o_091_noael_009"}

sccs_o_091.pdf

SOURCE_SUBDIR=sccs_o_091; REPORT_TITLE=OPINION ON Soytrimonium chloride COLIPA n° P72; OPINION_NUMBER=SCCS/1464/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 April 2006; VALUE_TEXT=9.9; EFFECT=SCCS/1464/12 Opinion on soytrimonium chloride (P72) ___________________________________________________________________________________________ 33 B. Steartrimonium chloride - dermal administration, rat Under the test conditions used, steartrimonium chloride was not found to be foetotoxic and teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was about 12.5 mg steartrimonium chloride/kg bw/day (highest concentration tested). Ref.: 1 (subm 2004) Taken from SCCS/1246/09 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstearylammonium chloride and trimethylstearylammonium chloride were investigated upon topical application of concentrations up to 9.9%, 6.6% and 2.5%, respectively. The authors conclude that, wi; CITATION=Ref.: 1 (subm 2004) Taken from SCCS/1246/09 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstear; CITATION_NUMBERS=[1,2004,1246,9,1983]; REFERENCE=Ref.: 1 (subm 2004) Taken from SCCS/1246/09 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstear; DETAILS_JSON={"cas_number":"61790-41-8","citation":"Ref.: 1 (subm 2004) Taken from SCCS/1246/09 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstear","dose":"","duration":"","effect":"SCCS/1464/12 Opinion on soytrimonium chloride (P72) ___________________________________________________________________________________________ 33 B. Steartrimonium chloride - dermal administration, rat Under the test conditions used, steartrimonium chloride was not found to be foetotoxic and teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was about 12.5 mg steartrimonium chloride/kg bw/day (highest concentration tested). Ref.: 1 (subm 2004) Taken from SCCS/1246/09 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstearylammonium chloride and trimethylstearylammonium chloride were investigated upon topical application of concentrations up to 9.9%, 6.6% and 2.5%, respectively. The authors conclude that, wi","endpoint":"developmental toxicity","ingredient":"s are allowed for other uses than preservation.","loael_value":"","noael_unit":"%","noael_value":"9.9","page":33,"route":"dermal","species":"rat","study_id":"sccs_o_091_noael_009"}

sccs_o_091.pdf

SOURCE_SUBDIR=sccs_o_091; REPORT_TITLE=OPINION ON Soytrimonium chloride COLIPA n° P72; OPINION_NUMBER=SCCS/1464/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 April 2006; VALUE_TEXT=10; DOSE=None of these effects was observed at the lowest tested dosage level of 10 mg/kg bw/day.; EFFECT=12 months) oral study with Cetrimonium Bromide in the rat indicated that the test compound may potentially prevent proper nutrition by increasing the rate of gastric emptying and intestinal transit and/or by interfering with the absorption of nutritional substances and reduced skeletal growth. The males displayed a reduced relative liver weight. None of these effects was observed at the lowest tested dosage level of 10 mg/kg bw/day. This dosage can be considered as a conservative NOAEL of Cetrimonium Bromide. This NOAEL is also comparable to or lower than other NOAELs of similar quaternary alkyl or aryl trimethylammonium compounds (reported range 12.5 – 125 mg/kg bw/d (Ref. 4, 31). Developmental toxicity Dermal developmental toxicity studies with Cetrimonium chloride in the rabbit and the rat revealed dose-dependent irritant effects, but no increased incidence of foetal malformations nor developmental variations in the treated groups compared to controls were observed. Cetrimonium chloride was found to be non-foetotoxic and non; CITATION=(Ref. 4, 31); CITATION_NUMBERS=[4,31]; REFERENCE=(Ref. 4, 31); DETAILS_JSON={"cas_number":"61790-41-8","citation":"(Ref. 4, 31)","dose":"None of these effects was observed at the lowest tested dosage level of 10 mg/kg bw/day.","duration":"12 months","effect":"12 months) oral study with Cetrimonium Bromide in the rat indicated that the test compound may potentially prevent proper nutrition by increasing the rate of gastric emptying and intestinal transit and/or by interfering with the absorption of nutritional substances and reduced skeletal growth. The males displayed a reduced relative liver weight. None of these effects was observed at the lowest tested dosage level of 10 mg/kg bw/day. This dosage can be considered as a conservative NOAEL of Cetrimonium Bromide. This NOAEL is also comparable to or lower than other NOAELs of similar quaternary alkyl or aryl trimethylammonium compounds (reported range 12.5 – 125 mg/kg bw/d (Ref. 4, 31). Developmental toxicity Dermal developmental toxicity studies with Cetrimonium chloride in the rabbit and the rat revealed dose-dependent irritant effects, but no increased incidence of foetal malformations nor developmental variations in the treated groups compared to controls were observed. Cetrimonium chloride was found to be non-foetotoxic and non","endpoint":"developmental toxicity","ingredient":"s are allowed for other uses than preservation.","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":39,"route":"oral","species":"rat","study_id":"sccs_o_091_noael_011"}

sccs_o_091.pdf

SOURCE_SUBDIR=sccs_o_091; REPORT_TITLE=OPINION ON Soytrimonium chloride COLIPA n° P72; OPINION_NUMBER=SCCS/1464/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 April 2006; VALUE_TEXT=125; DOSE=an other NOAELs of similar quaternary alkyl or aryl trimethylammonium compounds (reported range 12.5 – 125 mg/kg bw/d (Ref.; EFFECT=an other NOAELs of similar quaternary alkyl or aryl trimethylammonium compounds (reported range 12.5 – 125 mg/kg bw/d (Ref. 4, 31). Developmental toxicity Dermal developmental toxicity studies with Cetrimonium chloride in the rabbit and the rat revealed dose-dependent irritant effects, but no increased incidence of foetal malformations nor developmental variations in the treated groups compared to controls were observed. Cetrimonium chloride was found to be non-foetotoxic and non-teratogenic in both species. The NOEL for maternal systemic toxicity and embryo-foetal toxicity appeared to be 40 mg Cetrimonium chloride/kg bw/day for the rabbit and 12.5 mg Cetrimonium chloride/kg bw/day for the rat. Genotoxicity/Mutagenicity Apart from some shortcomings in the tests conducted, the results do not indicate a mutagenic/genotoxic potential of Cetrimonium, Steartrimonium or Behentrimonium Chloride. However, due to the unsaturated hydrocarbon chain of oleyl trimethylammonium, the predominant substance in the mixture, Soytrimonium Chlor; CITATION=(Ref. 4, 31); CITATION_NUMBERS=[4,31]; REFERENCE=(Ref. 4, 31); DETAILS_JSON={"cas_number":"61790-41-8","citation":"(Ref. 4, 31)","dose":"an other NOAELs of similar quaternary alkyl or aryl trimethylammonium compounds (reported range 12.5 – 125 mg/kg bw/d (Ref.","duration":"Developmental","effect":"an other NOAELs of similar quaternary alkyl or aryl trimethylammonium compounds (reported range 12.5 – 125 mg/kg bw/d (Ref. 4, 31). Developmental toxicity Dermal developmental toxicity studies with Cetrimonium chloride in the rabbit and the rat revealed dose-dependent irritant effects, but no increased incidence of foetal malformations nor developmental variations in the treated groups compared to controls were observed. Cetrimonium chloride was found to be non-foetotoxic and non-teratogenic in both species. The NOEL for maternal systemic toxicity and embryo-foetal toxicity appeared to be 40 mg Cetrimonium chloride/kg bw/day for the rabbit and 12.5 mg Cetrimonium chloride/kg bw/day for the rat. Genotoxicity/Mutagenicity Apart from some shortcomings in the tests conducted, the results do not indicate a mutagenic/genotoxic potential of Cetrimonium, Steartrimonium or Behentrimonium Chloride. However, due to the unsaturated hydrocarbon chain of oleyl trimethylammonium, the predominant substance in the mixture, Soytrimonium Chlor","endpoint":"developmental toxicity","ingredient":"s are allowed for other uses than preservation.","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"125","page":39,"route":"dermal","species":"rat","study_id":"sccs_o_091_noael_012"}

sccs_o_091.pdf

SOURCE_SUBDIR=sccs_o_091; REPORT_TITLE=OPINION ON Soytrimonium chloride COLIPA n° P72; OPINION_NUMBER=SCCS/1464/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 April 2006; VALUE_TEXT=10; DOSE=Suppression of growth was also observed with another quaternary ammonium compound, alkyl dimethyl benzyl ammonium chloride, at a dosage of about 63 mg/kg b.w./day (LOAEL, no NOAEL derived; study cited in Ref.; LOAEL_VALUE=10 mg/kg bw/day; EFFECT=inistered in large doses, may potentially prevent proper nutrition by increasing the rate of gastric emptying and intestinal transit and/or by interfering with the absorption of nutritional substances. Ref.: 35 (subm 2004) Comment Slight systemic effects were observed. Suppression of growth was also observed with another quaternary ammonium compound, alkyl dimethyl benzyl ammonium chloride, at a dosage of about 63 mg/kg b.w./day (LOAEL, no NOAEL derived; study cited in Ref. 31) For the calculation of the MoS, the NOAEL of 10 mg/kg bw/day for the analogous substance Cetrimonium bromide appears appropriate. Although this NOAEL may be the consequence of a local effect in the gastrointestinal tract, this NOAEL could be used as a conservative approach in the MoS calculation. B. Steartrimonium chloride - chronic toxicity No data submitted C. Behentrimonium chloride - chronic toxicity No data submitted D. Soytrimonium chloride - chronic toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity No new data. Taken from SCCS; CITATION=Ref.: 35 (subm 2004) Comment Slight systemic effects were observed; CITATION_NUMBERS=[35,2004]; REFERENCE=Ref.: 35 (subm 2004) Comment Slight systemic effects were observed; DETAILS_JSON={"cas_number":"61790-41-8","citation":"Ref.: 35 (subm 2004) Comment Slight systemic effects were observed","dose":"Suppression of growth was also observed with another quaternary ammonium compound, alkyl dimethyl benzyl ammonium chloride, at a dosage of about 63 mg/kg b.w./day (LOAEL, no NOAEL derived; study cited in Ref.","duration":"chronic","effect":"inistered in large doses, may potentially prevent proper nutrition by increasing the rate of gastric emptying and intestinal transit and/or by interfering with the absorption of nutritional substances. Ref.: 35 (subm 2004) Comment Slight systemic effects were observed. Suppression of growth was also observed with another quaternary ammonium compound, alkyl dimethyl benzyl ammonium chloride, at a dosage of about 63 mg/kg b.w./day (LOAEL, no NOAEL derived; study cited in Ref. 31) For the calculation of the MoS, the NOAEL of 10 mg/kg bw/day for the analogous substance Cetrimonium bromide appears appropriate. Although this NOAEL may be the consequence of a local effect in the gastrointestinal tract, this NOAEL could be used as a conservative approach in the MoS calculation. B. Steartrimonium chloride - chronic toxicity No data submitted C. Behentrimonium chloride - chronic toxicity No data submitted D. Soytrimonium chloride - chronic toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity No new data. Taken from SCCS","endpoint":"genotoxicity","ingredient":"s are allowed for other uses than preservation.","loael_value":"10 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"10","page":31,"route":"","species":"","study_id":"sccs_o_091_noael_005"}

sccs_o_091.pdf

SOURCE_SUBDIR=sccs_o_091; REPORT_TITLE=OPINION ON Soytrimonium chloride COLIPA n° P72; OPINION_NUMBER=SCCS/1464/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 April 2006; VALUE_TEXT=10; DOSE=Suppression of growth was also observed with another quaternary ammonium compound, alkyl dimethyl benzyl ammonium chloride, at a dosage of about 63 mg/kg b.w./day (LOAEL, no NOAEL derived; study cited in Ref.; LOAEL_VALUE=10 mg/kg bw/day; EFFECT=g and intestinal transit and/or by interfering with the absorption of nutritional substances. Ref.: 35 (subm 2004) Comment Slight systemic effects were observed. Suppression of growth was also observed with another quaternary ammonium compound, alkyl dimethyl benzyl ammonium chloride, at a dosage of about 63 mg/kg b.w./day (LOAEL, no NOAEL derived; study cited in Ref. 31) For the calculation of the MoS, the NOAEL of 10 mg/kg bw/day for the analogous substance Cetrimonium bromide appears appropriate. Although this NOAEL may be the consequence of a local effect in the gastrointestinal tract, this NOAEL could be used as a conservative approach in the MoS calculation. B. Steartrimonium chloride - chronic toxicity No data submitted C. Behentrimonium chloride - chronic toxicity No data submitted D. Soytrimonium chloride - chronic toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity No new data. Taken from SCCS/1246/09; CITATION=Ref.: 35 (subm 2004) Comment Slight systemic effects were observed; CITATION_NUMBERS=[35,2004]; REFERENCE=Ref.: 35 (subm 2004) Comment Slight systemic effects were observed; DETAILS_JSON={"cas_number":"61790-41-8","citation":"Ref.: 35 (subm 2004) Comment Slight systemic effects were observed","dose":"Suppression of growth was also observed with another quaternary ammonium compound, alkyl dimethyl benzyl ammonium chloride, at a dosage of about 63 mg/kg b.w./day (LOAEL, no NOAEL derived; study cited in Ref.","duration":"chronic","effect":"g and intestinal transit and/or by interfering with the absorption of nutritional substances. Ref.: 35 (subm 2004) Comment Slight systemic effects were observed. Suppression of growth was also observed with another quaternary ammonium compound, alkyl dimethyl benzyl ammonium chloride, at a dosage of about 63 mg/kg b.w./day (LOAEL, no NOAEL derived; study cited in Ref. 31) For the calculation of the MoS, the NOAEL of 10 mg/kg bw/day for the analogous substance Cetrimonium bromide appears appropriate. Although this NOAEL may be the consequence of a local effect in the gastrointestinal tract, this NOAEL could be used as a conservative approach in the MoS calculation. B. Steartrimonium chloride - chronic toxicity No data submitted C. Behentrimonium chloride - chronic toxicity No data submitted D. Soytrimonium chloride - chronic toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity No new data. Taken from SCCS/1246/09","endpoint":"genotoxicity","ingredient":"s are allowed for other uses than preservation.","loael_value":"10 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"10","page":31,"route":"","species":"","study_id":"sccs_o_091_noael_006"}

sccs_o_091.pdf

SOURCE_SUBDIR=sccs_o_091; REPORT_TITLE=OPINION ON Soytrimonium chloride COLIPA n° P72; OPINION_NUMBER=SCCS/1464/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 April 2006; VALUE_TEXT=10; DOSE=Suppression of growth was also observed with another quaternary ammonium compound, alkyl dimethyl benzyl ammonium chloride, at a dosage of about 63 mg/kg b.w./day (LOAEL, no NOAEL derived; study cited in Ref.; LOAEL_VALUE=10 mg/kg bw/day; EFFECT=ubstances. Ref.: 35 (subm 2004) Comment Slight systemic effects were observed. Suppression of growth was also observed with another quaternary ammonium compound, alkyl dimethyl benzyl ammonium chloride, at a dosage of about 63 mg/kg b.w./day (LOAEL, no NOAEL derived; study cited in Ref. 31) For the calculation of the MoS, the NOAEL of 10 mg/kg bw/day for the analogous substance Cetrimonium bromide appears appropriate. Although this NOAEL may be the consequence of a local effect in the gastrointestinal tract, this NOAEL could be used as a conservative approach in the MoS calculation. B. Steartrimonium chloride - chronic toxicity No data submitted C. Behentrimonium chloride - chronic toxicity No data submitted D. Soytrimonium chloride - chronic toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity No new data. Taken from SCCS/1246/09; CITATION=Ref.: 35 (subm 2004) Comment Slight systemic effects were observed; CITATION_NUMBERS=[35,2004]; REFERENCE=Ref.: 35 (subm 2004) Comment Slight systemic effects were observed; DETAILS_JSON={"cas_number":"61790-41-8","citation":"Ref.: 35 (subm 2004) Comment Slight systemic effects were observed","dose":"Suppression of growth was also observed with another quaternary ammonium compound, alkyl dimethyl benzyl ammonium chloride, at a dosage of about 63 mg/kg b.w./day (LOAEL, no NOAEL derived; study cited in Ref.","duration":"chronic","effect":"ubstances. Ref.: 35 (subm 2004) Comment Slight systemic effects were observed. Suppression of growth was also observed with another quaternary ammonium compound, alkyl dimethyl benzyl ammonium chloride, at a dosage of about 63 mg/kg b.w./day (LOAEL, no NOAEL derived; study cited in Ref. 31) For the calculation of the MoS, the NOAEL of 10 mg/kg bw/day for the analogous substance Cetrimonium bromide appears appropriate. Although this NOAEL may be the consequence of a local effect in the gastrointestinal tract, this NOAEL could be used as a conservative approach in the MoS calculation. B. Steartrimonium chloride - chronic toxicity No data submitted C. Behentrimonium chloride - chronic toxicity No data submitted D. Soytrimonium chloride - chronic toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity No new data. Taken from SCCS/1246/09","endpoint":"genotoxicity","ingredient":"s are allowed for other uses than preservation.","loael_value":"10 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"10","page":31,"route":"","species":"","study_id":"sccs_o_091_noael_007"}

sccs_o_091.pdf

SOURCE_SUBDIR=sccs_o_091; REPORT_TITLE=OPINION ON Soytrimonium chloride COLIPA n° P72; OPINION_NUMBER=SCCS/1464/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 April 2006; VALUE_TEXT=10; DOSE=There were no treatment-related effects on body weight, haematology, organ weight, gross necropsy findings or histopathology, except for treated areas of the skin that showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair follicles, partly with encrustation and exudate.; EFFECT=pically disappeared by the end of the study. There were no treatment-related effects on body weight, haematology, organ weight, gross necropsy findings or histopathology, except for treated areas of the skin that showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair follicles, partly with encrustation and exudate. The US National Toxicology Programme report concluded that the toxic response only consists of skin irritation, and proposed a NOAEL value of 10 mg/kg bw/day for systemic effects. Ref. 34 (= pp.170-171 of Ref.1, submission 2004) Conclusion There were no treatment-related effects on body weight, haematology, organ weight, gross necropsy findings or histopathology, except for treated areas of the skin that showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair follicles, partly with encrustation and exudate. The US National Toxicology Programme report concluded that the to; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"61790-41-8","citation":"","dose":"There were no treatment-related effects on body weight, haematology, organ weight, gross necropsy findings or histopathology, except for treated areas of the skin that showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair follicles, partly with encrustation and exudate.","duration":"","effect":"pically disappeared by the end of the study. There were no treatment-related effects on body weight, haematology, organ weight, gross necropsy findings or histopathology, except for treated areas of the skin that showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair follicles, partly with encrustation and exudate. The US National Toxicology Programme report concluded that the toxic response only consists of skin irritation, and proposed a NOAEL value of 10 mg/kg bw/day for systemic effects. Ref. 34 (= pp.170-171 of Ref.1, submission 2004) Conclusion There were no treatment-related effects on body weight, haematology, organ weight, gross necropsy findings or histopathology, except for treated areas of the skin that showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair follicles, partly with encrustation and exudate. The US National Toxicology Programme report concluded that the to","endpoint":"irritation","ingredient":"s are allowed for other uses than preservation.","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":30,"route":"","species":"","study_id":"sccs_o_091_noael_002"}

sccs_o_091.pdf

SOURCE_SUBDIR=sccs_o_091; REPORT_TITLE=OPINION ON Soytrimonium chloride COLIPA n° P72; OPINION_NUMBER=SCCS/1464/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 April 2006; VALUE_TEXT=24-26; DOSE=The study authors conclude that the forestomach and stomach changes observed at 300 mg/kg bw/day can be considered to be a result of local irritation and therefore are not indicative of systemic toxicity.; EFFECT=no treatment-related changes in any group. Conclusion (taken from Ref. 1): The study authors conclude that the forestomach and stomach changes observed at 300 mg/kg bw/day can be considered to be a result of local irritation and therefore are not indicative of systemic toxicity. The slight weight changes of spleen and adrenals and the increase in serum ALT activity were regarded as possible signs of some systemic toxicity. The dosage of 100 mg/kg bw/day was considered to be the no-observed-adverse-effect- level (NOAEL) of Dehyquart A-CA (24-26% cetrimonium chloride in water, corresponding to about 25 mg/kg bw/day of the active substance) in this study. Ref.: 33 B. Cetrimonium chloride - 28-day dermal administration in the rabbit In a study from 1978, 5 New Zealand albino rabbits/sex/group were treated cutaneously with the test substance for 5 days/week for 4 weeks at a dose of 0 or 10 mg/kg bw/day (0 or 0.5% aqueous solutions, respectively). The dosage volume was 2.0 ml/kg bw with an approximate exposure period of 6.5 to 7 h; CITATION=Ref.: 33 B; CITATION_NUMBERS=[33]; REFERENCE=Ref.: 33 B; DETAILS_JSON={"cas_number":"61790-41-8","citation":"Ref.: 33 B","dose":"The study authors conclude that the forestomach and stomach changes observed at 300 mg/kg bw/day can be considered to be a result of local irritation and therefore are not indicative of systemic toxicity.","duration":"28-day","effect":"no treatment-related changes in any group. Conclusion (taken from Ref. 1): The study authors conclude that the forestomach and stomach changes observed at 300 mg/kg bw/day can be considered to be a result of local irritation and therefore are not indicative of systemic toxicity. The slight weight changes of spleen and adrenals and the increase in serum ALT activity were regarded as possible signs of some systemic toxicity. The dosage of 100 mg/kg bw/day was considered to be the no-observed-adverse-effect- level (NOAEL) of Dehyquart A-CA (24-26% cetrimonium chloride in water, corresponding to about 25 mg/kg bw/day of the active substance) in this study. Ref.: 33 B. Cetrimonium chloride - 28-day dermal administration in the rabbit In a study from 1978, 5 New Zealand albino rabbits/sex/group were treated cutaneously with the test substance for 5 days/week for 4 weeks at a dose of 0 or 10 mg/kg bw/day (0 or 0.5% aqueous solutions, respectively). The dosage volume was 2.0 ml/kg bw with an approximate exposure period of 6.5 to 7 h","endpoint":"irritation","ingredient":"s are allowed for other uses than preservation.","loael_value":"","noael_unit":"%","noael_value":"24-26","page":29,"route":"dermal","species":"rabbit","study_id":"sccs_o_091_noael_001"}

sccs_o_091.pdf

SOURCE_SUBDIR=sccs_o_091; REPORT_TITLE=OPINION ON Soytrimonium chloride COLIPA n° P72; OPINION_NUMBER=SCCS/1464/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 April 2006; VALUE_TEXT=10; DOSE=170-171 of Ref.1, submission 2004) Conclusion There were no treatment-related effects on body weight, haematology, organ weight, gross necropsy findings or histopathology, except for treated areas of the skin that showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair fol...; EFFECT=170-171 of Ref.1, submission 2004) Conclusion There were no treatment-related effects on body weight, haematology, organ weight, gross necropsy findings or histopathology, except for treated areas of the skin that showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair follicles, partly with encrustation and exudate. The US National Toxicology Programme report concluded that the toxic response only consists of skin irritation, and proposed a NOAEL value of 10 mg/kg bw/day for systemic effects. C. Steartrimonium chloride - 28-day oral/dermal administration No data submitted D. Behentrimonium chloride - 28-day oral/dermal administration No data submitted E. Soytrimonium chloride - 28-day oral/dermal administration No data submitted 3.3.5.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity No data submitted 3.3.5.3 Chronic (> 12 months) toxicity No new data. Taken from SCCS/1246/09 A. Cetrimonium bromide - chronic toxicity; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"61790-41-8","citation":"","dose":"170-171 of Ref.1, submission 2004) Conclusion There were no treatment-related effects on body weight, haematology, organ weight, gross necropsy findings or histopathology, except for treated areas of the skin that showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair fol...","duration":"28-day","effect":"170-171 of Ref.1, submission 2004) Conclusion There were no treatment-related effects on body weight, haematology, organ weight, gross necropsy findings or histopathology, except for treated areas of the skin that showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair follicles, partly with encrustation and exudate. The US National Toxicology Programme report concluded that the toxic response only consists of skin irritation, and proposed a NOAEL value of 10 mg/kg bw/day for systemic effects. C. Steartrimonium chloride - 28-day oral/dermal administration No data submitted D. Behentrimonium chloride - 28-day oral/dermal administration No data submitted E. Soytrimonium chloride - 28-day oral/dermal administration No data submitted 3.3.5.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity No data submitted 3.3.5.3 Chronic (> 12 months) toxicity No new data. Taken from SCCS/1246/09 A. Cetrimonium bromide - chronic toxicity","endpoint":"repeated dose toxicity","ingredient":"s are allowed for other uses than preservation.","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":30,"route":"oral","species":"","study_id":"sccs_o_091_noael_003"}

sccs_o_091.pdf

SOURCE_SUBDIR=sccs_o_091; REPORT_TITLE=OPINION ON Soytrimonium chloride COLIPA n° P72; OPINION_NUMBER=SCCS/1464/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 April 2006; VALUE_TEXT=10; DOSE=Repeated dose toxicity A chronic (12 months) oral study with Cetrimonium Bromide in the rat indicated that the test compound may potentially prevent proper nutrition by increasing the rate of gastric emptying and intestinal transit and/or by interfering with the absorption of nutritional substances and reduced skeletal growth.; EFFECT=Repeated dose toxicity A chronic (12 months) oral study with Cetrimonium Bromide in the rat indicated that the test compound may potentially prevent proper nutrition by increasing the rate of gastric emptying and intestinal transit and/or by interfering with the absorption of nutritional substances and reduced skeletal growth. The males displayed a reduced relative liver weight. None of these effects was observed at the lowest tested dosage level of 10 mg/kg bw/day. This dosage can be considered as a conservative NOAEL of Cetrimonium Bromide. This NOAEL is also comparable to or lower than other NOAELs of similar quaternary alkyl or aryl trimethylammonium compounds (reported range 12.5 – 125 mg/kg bw/d (Ref. 4, 31). Developmental toxicity Dermal developmental toxicity studies with Cetrimonium chloride in the rabbit and the rat revealed dose-dependent irritant effects, but no increased incidence of foetal malformations nor developmental variations in the treated groups compared to controls were observed. Cetrimonium chloride was; CITATION=(Ref. 4, 31); CITATION_NUMBERS=[4,31]; REFERENCE=(Ref. 4, 31); DETAILS_JSON={"cas_number":"61790-41-8","citation":"(Ref. 4, 31)","dose":"Repeated dose toxicity A chronic (12 months) oral study with Cetrimonium Bromide in the rat indicated that the test compound may potentially prevent proper nutrition by increasing the rate of gastric emptying and intestinal transit and/or by interfering with the absorption of nutritional substances and reduced skeletal growth.","duration":"chronic","effect":"Repeated dose toxicity A chronic (12 months) oral study with Cetrimonium Bromide in the rat indicated that the test compound may potentially prevent proper nutrition by increasing the rate of gastric emptying and intestinal transit and/or by interfering with the absorption of nutritional substances and reduced skeletal growth. The males displayed a reduced relative liver weight. None of these effects was observed at the lowest tested dosage level of 10 mg/kg bw/day. This dosage can be considered as a conservative NOAEL of Cetrimonium Bromide. This NOAEL is also comparable to or lower than other NOAELs of similar quaternary alkyl or aryl trimethylammonium compounds (reported range 12.5 – 125 mg/kg bw/d (Ref. 4, 31). Developmental toxicity Dermal developmental toxicity studies with Cetrimonium chloride in the rabbit and the rat revealed dose-dependent irritant effects, but no increased incidence of foetal malformations nor developmental variations in the treated groups compared to controls were observed. Cetrimonium chloride was","endpoint":"repeated dose toxicity","ingredient":"s are allowed for other uses than preservation.","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":39,"route":"oral","species":"rat","study_id":"sccs_o_091_noael_010"}

sccs_o_091.pdf

SOURCE_SUBDIR=sccs_o_091; REPORT_TITLE=OPINION ON Soytrimonium chloride COLIPA n° P72; OPINION_NUMBER=SCCS/1464/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 17 April 2006; VALUE_TEXT=unclear:yo-preserved primary Syrian hamster embryo cells were cultivated and incubated with 0.1, 1.0 and 5.0 µg cetrimonium chloride/ml. The substance showed to be toxic at the highest concentration tested, though did not produce transformation at any of the doses tested. Ref.: 1, 40 (subm 2004) 3.3.8. Reproductive toxicity No new data. Taken from SCCS/1246/09 A. Cetrimonium chloride, dermal administration, rabbit Under the test conditions used, cetrimonium chloride was not found to be foetotoxic and teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity appeared to be 40 mg cetrimonium chloride/kg bw/day. Ref.: 41 (subm 2004); EFFECT=yo-preserved primary Syrian hamster embryo cells were cultivated and incubated with 0.1, 1.0 and 5.0 µg cetrimonium chloride/ml. The substance showed to be toxic at the highest concentration tested, though did not produce transformation at any of the doses tested. Ref.: 1, 40 (subm 2004) 3.3.8. Reproductive toxicity No new data. Taken from SCCS/1246/09 A. Cetrimonium chloride, dermal administration, rabbit Under the test conditions used, cetrimonium chloride was not found to be foetotoxic and teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity appeared to be 40 mg cetrimonium chloride/kg bw/day. Ref.: 41 (subm 2004); CITATION=Ref.: 1, 40 (subm 2004) 3; CITATION_NUMBERS=[1,40,2004,3]; REFERENCE=Ref.: 1, 40 (subm 2004) 3; DETAILS_JSON={"cas_number":"61790-41-8","citation":"Ref.: 1, 40 (subm 2004) 3","dose":"","duration":"","effect":"yo-preserved primary Syrian hamster embryo cells were cultivated and incubated with 0.1, 1.0 and 5.0 µg cetrimonium chloride/ml. The substance showed to be toxic at the highest concentration tested, though did not produce transformation at any of the doses tested. Ref.: 1, 40 (subm 2004) 3.3.8. Reproductive toxicity No new data. Taken from SCCS/1246/09 A. Cetrimonium chloride, dermal administration, rabbit Under the test conditions used, cetrimonium chloride was not found to be foetotoxic and teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity appeared to be 40 mg cetrimonium chloride/kg bw/day. Ref.: 41 (subm 2004)","endpoint":"reproductive toxicity","ingredient":"s are allowed for other uses than preservation.","loael_value":"","noael_unit":"","noael_value":"unclear:yo-preserved primary Syrian hamster embryo cells were cultivated and incubated with 0.1, 1.0 and 5.0 µg cetrimonium chloride/ml. The substance showed to be toxic at the highest concentration tested, though did not produce transformation at any of the doses tested. Ref.: 1, 40 (subm 2004) 3.3.8. Reproductive toxicity No new data. Taken from SCCS/1246/09 A. Cetrimonium chloride, dermal administration, rabbit Under the test conditions used, cetrimonium chloride was not found to be foetotoxic and teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity appeared to be 40 mg cetrimonium chloride/kg bw/day. Ref.: 41 (subm 2004)","page":32,"route":"dermal","species":"rabbit","study_id":"sccs_o_091_noael_008"}

sccs_o_091.pdf